Senior Associate Quality Assurance

4w1 month ago

Pfizer

Visakhapatnam, IN · Full-time · INR 1,200,000 – INR 1,800,000

About this role

Pfizer is seeking a Senior Associate Quality Assurance to join our team in Visakhapatnam, India. This role is central to ensuring compliance and quality across manufacturing operations, with a focus on validation, maintenance, and engineering processes.

In this on-premise position, you will apply your expertise in change management, risk assessment, and equipment qualification to support drug product process validations. You will review and approve documentation related to equipment and utility qualifications, water systems, and HVAC systems, ensuring alignment with cGMP and regulatory requirements.

You will collaborate with cross-functional teams, including engineering and manufacturing, to assess change controls and investigate quality events. Your strong interpersonal skills will enable effective communication with all levels of the organization, fostering a compliance-driven culture.

This role offers the opportunity to grow your technical writing and managerial skills while working on complex validation challenges. Pfizer is an equal opportunity employer committed to diversity and inclusion in the workplace.

Requirements

B.Pharm, M.Pharm, or M.Sc degree
6-8 years of experience in Validation, Maintenance, Engineering, or Quality
Core competency in change management process and risk assessment principles and tools
Advanced competency in validation of manufacturing equipment and drug product process validations
Knowledge of cGMP and regulatory requirements with a compliance-driven approach
Technical skills in validation principles for equipment and utility qualifications, water systems, and HVAC systems
Understanding of manufacturing area drawings, layouts, air flow, material flow, and building management systems
Strong technical writing ability to create documentation that is accurate, complete, and unambiguous

Responsibilities

Manage and oversee the change management process for manufacturing equipment and processes
Conduct risk assessments using established principles and tools to support quality decisions
Review and approve validation documentation for equipment, utilities, water systems, and HVAC systems
Support drug product process validations and ensure compliance with regulatory requirements
Evaluate and assess change control requests to maintain validated state of manufacturing areas
Apply knowledge of manufacturing activities including dispensing, solution preparation, filling, terminal sterilization, visual inspection, labeling, and packing
Create accurate, complete, and concise technical documentation and reports for quality investigations
Monitor process progress and results, holding team members accountable for assigned tasks and objectives

Benefits

On-premise work location at Pfizer's Visakhapatnam site
Equal opportunity employer with inclusive hiring practices
Access to Pfizer's candidate AI-use guidelines for transparent recruitment process